Harnessing Cloud PLM and AI for Enhanced Productivity

BUSINESS CHALLENGES

During its early startup phase, Galvanize maintained product and quality documentation via paper. Implementing product changes was an arduous, time-consuming process, since engineering change orders (ECOs) had to be routed sequentially to each stakeholder for review and approval.

As the company grew, their product documentation and quality processes became more extensive. Because records were stored in file cabinets and other physical locations, employees had difficulty finding documents and identifying the latest revision. Consequently, compiling documentation during regulatory audits took considerable time. “In today’s regulatory environment, auditors expect a fast turnaround time. Failure to quickly retrieve records could result in a nonconformance,” noted Penny Dalton, Associate Director of Configuration Management and Document Control at Galvanize Therapeutics.

“Our reliance on paper made it challenging to maintain bills of materials (BOMs). What’s more, it created a regulatory burden. We needed to ensure information integrity as we implemented changes and released BOMs to our contract manufacturers (CMs). Our primary concern was avoiding product recall issues,” stated Deborah Sheffield, SVP of Regulatory and Quality at Galvanize Therapeutics.

“The hours spent sifting through piles of paper, searching for information, or recreating lost records detracted from our innovation initiatives. We needed a robust digital system to enhance efficiencies while ensuring accuracy and compliance,” added Dalton.

To address these challenges, the organization decided to invest in an all-in-one product lifecycle management (PLM) and quality management system (QMS) solution. They eventually selected Arena.

THE SOLUTION

Connected PLM and QMS

Arena brings together the entire product record and associated quality processes in a single digitized system. Engineering changes link directly to the product BOM, ensuring that Galvanize’s teams always access accurate and current information. Arena’s automated change review and approval routings significantly reduce ECO cycle times, enabling the company to release products faster.

By connecting corrective and preventive actions (CAPAs), complaints, inspections, and other quality processes to the product record, Arena provides Galvanize complete visibility and traceability to ensure closed-loop quality and drive continuous improvement. Additionally, the ability to easily search and retrieve up-to-date QMS documentation in Arena helps Galvanize demonstrate compliance and expedite their audits.

Arena’s secure and well-documented application programming interfaces (APIs) enable Galvanize to seamlessly connect all the critical PLM and QMS information with other enterprise systems to accomplish their unique business processes.